Compositions and methods for treating systemic lupus erythematosus

Abstract

The present invention is directed to compositions and methods for modulating c-Rel-dependent cytokine production without materially altering the level of expression of NFκB and/or the amount of IκB. The present invention is also directed to screening for modulators of c-Rel activity as determined by assaying for altered subcellular localization of c-Rel but where the level of expression of NFκB and/or the amount of IκB is materially unaltered.

1 - 41 . (canceled) 
     
     
         42 . A method of treating a neurological disease, disorder or condition, the method comprising administering to a subject in need thereof, a pharmaceutical composition comprising an amount of Compound 2: N-(3-methyl-benzylidene)-N′-[6-morpholin-4-yl-2-(2-pyridin-2-yl-ethoxy)-pyrimidin-4-yl]-hydrazine. 
     
     
         43 . The method of  claim 42 , wherein the neurological disease, disorder or condition is selected from the group consisting of multiple sclerosis, AIDS dementia complex, acute transverse myelitis, Huntington's Chorea, senile chorea, Parkinson's disease, progressive supranucleo palsy, spinal ataxia, Friedreich's ataxia, amyotrophic lateral sclerosis, infantile spinal muscular atrophy, juvenile spinal muscular atrophy, Down's Syndrome in middle age; diffuse Lewy body disease, senile dementia of Lewy body type, Wernicke-Korsakoff syndrome, Creutzfeldt-Jakob disease; subacute sclerosing panencephalitis, Hallerrorden-Spatz disease, and dementia pugilistica. 
     
     
         44 . The method of  claim 43 , wherein the neurological disease, disorder or condition is amyotrophic lateral sclerosis. 
     
     
         45 . The method of  claim 43 , wherein the neurological disease, disorder or condition is a form of dementia. 
     
     
         46 . The method of  claim 42 , wherein the pharmaceutical composition is formulated for a route of administration selected from intravenous, intranasal, or oral. 
     
     
         47 . The method of  claim 46 , wherein the pharmaceutical composition is formulated for intravenous administration. 
     
     
         48 . The method of  claim 47 , wherein the amount of Compound 2 in the composition is from 1 to 50 mg per kilogram of the subject's body weight. 
     
     
         49 . The method of  claim 46 , wherein the pharmaceutical composition is formulated for intranasal administration. 
     
     
         50 . The method of  claim 49 , wherein the amount of Compound 2 in the composition is from 0.1 to 50 mg per kilogram of the subject's body weight. 
     
     
         51 . The method of  claim 46 , wherein the pharmaceutical composition is formulated for oral administration. 
     
     
         52 . The method of  claim 51 , wherein the pharmaceutical composition is a tablet, caplet, hard gelatin capsule, soft gelatin capsules, troche, dragee, dispersion, suspension, or solution. 
     
     
         53 . The method of  claim 52 , wherein the amount of Compound 2 in the composition is from 1 microgram to 500 mg, from 100 micrograms to 5 mg, or from 1 microgram to 50 micrograms per kilogram of the subject's body weight. 
     
     
         54 . The method of  claim 53 , wherein the pharmaceutical composition is a controlled release formulation. 
     
     
         55 . The method of  claim 54 , further comprising administering to the subject an additional prophylactic or therapeutic agent. 
     
     
         56 . The method of  claim 55 , wherein the additional prophylactic or therapeutic agent is administered in the same dosage form as Compound 2. 
     
     
         57 . The method of  claim 42 , wherein the subject is human. 
     
     
         58 . The method of  claim 44 , wherein the subject is human.